Study Questions:

What are the early outcomes associated with transcatheter mitral valve replacement (TMVR) using the new Intrepid TMVR system?

Methods:

The Intrepid TMVR system includes a self-expanding, nitinol valve with bovine pericardial leaflets; and a transapical (35 Fr sheath) delivery system. Patients with symptomatic severe mitral regurgitation (MR) with no or minimal valve calcification and left ventricular ejection fraction (LVEF) >20% who were deemed high or extreme risk by local heart teams were enrolled in a global pilot study at 14 sites in the United States, Australia, and Europe.

Conclusions:

TMVR with the Intrepid valve system was feasible in a population at high- or extreme-risk for conventional MVR. The authors concluded that these results could help inform trial design of TMVR in lower-risk patients with severe MV regurgitation.

Perspective:

Transcatheter aortic valve replacement (TAVR) is established as a standard of care among intermediate- and higher-risk patients with severe, symptomatic aortic stenosis. In contrast, TMVR is an emerging therapy with no device currently approved for clinical use in the United States. Challenges in performing TMVR compared to TAVR include those related to access, and the unique geometry of the MV (including a noncircular, nonplanar, and nonrigid annulus). This pilot study of a new, self-expanding nitinol valve in 50 patients at high or extreme surgical risk found successful implantation in 96% of patients, a short and reproducible procedure with a minimal learning curve, reduction of MR to mild or none in all implanted patients, no device malfunction during limited (median 173 days) follow-up, and symptomatic and quality-of-life improvement among survivors.